FDA 510(k)

Elecsys 皮质醇 II，皮质醇 II CalSet

K号: K152227 · 2016-04-27

决定日期2016-04-27

产品代码JFT

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Elecsys Cortisol II, Cortisol II CalSet is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2016-04-27 under 510(k) number K152227. The device is classified under product code JFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Cortisol II, Cortisol II CalSet?

Elecsys Cortisol II, Cortisol II CalSet is a medical device that received FDA 510(k) clearance on 2016-04-27. The listed applicant is Roche Diagnostics. The 510(k) number is K152227.

When did Elecsys Cortisol II, Cortisol II CalSet receive FDA 510(k) clearance?

Elecsys Cortisol II, Cortisol II CalSet received FDA 510(k) clearance on 2016-04-27, under 510(k) number K152227.

Who is the listed applicant for Elecsys Cortisol II, Cortisol II CalSet?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Elecsys Cortisol II, Cortisol II CalSet?

The FDA product code for Elecsys Cortisol II, Cortisol II CalSet is JFT.

列明Roche Diagnostics为申报人的其他记录

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